Ethical analysis

The ethical analysis domain considers prevalent social and moral norms relevant to the technology in question. It involves an understanding of implementing or not implementing a healthcare technology in two respects: with regard to the prevailing societal values and with regard to the norms and values the technology itself constructs when it is put into use. The moral value that societies attribute to the consequences of implementing a technology is affected by socio-political, legal, cultural and religious and economic differences. However, many ethical considerations are common to all cultures and societies. There are also moral and ethical issues related to consequences of performing a health technology assessment (e.g. ethical consequences of choosing specific endpoints and whether there are ethical problems related to economic evaluation). (1)

Ethical analyses in HTA are realized in different ways (2):

write an expert statement,

review the literature narratively,

review the literature systematically.

Different methods and approaches (3) to analyze ethical aspects in HTA do exist and are applied in some of the published HTA reports. These methods publications do not provide detailed guidance on how and where to find relevant literature, which is the aim of this chapter.

Sources to search

Medical ethics is an interdisciplinary field of research (4). Searching beyond the major biomedical databases is recommended. Rauprich et al. (5) compared the search process and the results of MEDLINE and the ethics database BELIT and found in their examples only a small overlap of 3-4% between the two. Fangerau (4) identified the highest quantity of Medical Ethics journal literature by searching a combination of databases, as Current Contents, MEDLINE, Research Alert, Social Sciences Citation Index, Embase, AgeLine, CINAHL, E-psyche, Sociological Abstracts, and Family Index.

Droste et al. (6) recommended, depending on the topic in question, the following sources (searchable in English language) in information retrieval for ethical issues:

As ethical aspects are related to individual and public preferences, norms and values (sense of morality) they are regionally and nationally different. Thus, for thorough reflections on ethical issues relevant national databases are of interest too (6). In this context, Dracos introduced the Italian bioethics database SIBIL (7).

Ethical aspects as well as legal aspects refer to international or supranational rules and regulations and in particular to national law. For these reasons the use of the information sources recommended for legal issues are of interest too (ref. chapter “Legal aspects”).

Further, hand-searching for non-indexed journals, searching of the web pages of relevant ethics institutes or searching for experts may be considered (6).

Designing search strategies

No internationally established standard exists on how to develop search strategies on ethical analysis related to health technologies (6). A study by Droste et al. (6) introduced a proposal for an information retrieval procedure similar to the workflow of information retrieval for effectiveness assessments.

One should first try to identify relevant laws, rules and regulations, and the ethical issues relevant to the topic of interest and the methods approach chosen for analysis, then start the workflow:

Step 1: Translation of the search question respective definition of the search components by using the PICO scheme and additional components.

Step 2: Concept building by modeling and linking search components with Boolean operators.

Step 7: Saving of retrieval results and standardized reporting of the process and results.

Step 8: Final quality check and calculation of precision and recall.

In the first step, it is recommended to add an additional component related to the ethical aspects to the PICO scheme describing the population, intervention, comparator, and outcomes of interest (PICOE). In databases that allow advanced searching, subject headings and text words describing the relevant ethical issues are then combined component by component with the Boolean operator “AND”. The final steps of the proposed workflow are the final quality check, saving the results and reporting the search process transparent and reproducible manner.

Some support is provided by Kahn et al. (8, 9) who presented the Bioethics Thesaurus Keywords and MeSH equivalents as well as some recommendations on how to find publications by entering MeSH Headings and free-text queries in PubMed and further databases provided by the National Library of Medicine (NLM). Additionally, the National Reference Center for Bioethics Literature (10) published a guide on the bioethics literature databases at the Georgetown University and the National Library of Medicine (NLM), on BELIT (German Reference Centre for Ethics in the Life Sciences, DRZE) and the Global Ethics Observatory (UNESCO).

The paper of Droste et al. (6) provides (besides the overview of relevant databases) relevant subject headings for searching for ethical aspects in MEDLINE and Embase. The use of less sophisticated search strategies has to be to be considered in other sources.

There have been undertaken some efforts to develop a standard search filter for identifying publications on values by Petrova et al. (11) but the study results show that a) “values” are hard to define and topic specific, b) “values” are not representable by a brief search filter (124 MeSH terms, 144 free text words were processed), and c) sensitivity / external validity is too low to be applied in HTA or systematic reviews.

Some overlap does exist between ethical, legal and social aspects of health technologies (6). For example, issues of patient autonomy are part of each of these aspects. To avoid duplication of work, joint information retrieval processes for these three aspects may therefore be considered.

Some information on ethical aspects of health technologies is published in qualitative studies. Thus, it is recommended to search for such studies from various disciplines too. Guidance on how to search for qualitative research will later be supplemented by a separate chapter.